PCI vs. CABG in UPLM-ISR (LM-DRAGON)

Long-term Outcomes Following Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Treating In-stent Restenosis in Unprotected Left Main Coronary Artery: Multicenter LM-DRAGON Registry

Left main (LM) coronary artery disease is associated with high morbidity and mortality owing to the large myocardial territory at risk for ischemia. Evidence from randomized controlled trials supports that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for LM disease is an acceptable treatment strategy compared with coronary artery bypass graft surgery in patients with low or intermediate anatomic complexity. However in-stent restenosis (ISR) after DES in LM disease is still occurring with an incidence of 9,7%. Studies comparing the percutaneous coronary intervention with coronary artery bypass grafting (CABG) in the treatment of in-stent restenosis in unprotected left main have been scarce. While surgical revascularization is considered to be the standard treatment for this kind of stent failure, owing to a high risk of perioperative morbidity and mortality, the restoration of flow with PCI may be a reliable alternative. Additionally, it is not clear whether re-PCI is safe in these patients. Therefore, the purpose of the present study was to compare long-term outcomes following PCI or CABG for UPLM-ISR disease.

Study Overview

• Status: Completed
• Conditions: Left Main Coronary Artery Disease; Restenosis, Coronary; PTCA Left Main Artery Complications
• Intervention / Treatment: Procedure: PCI vs. CABG

• Study Type: Observational
• Enrollment (Actual): 305

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy
    • Fabrizio D'Ascenzo
• Poland
  • Białystok, Poland
    • Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
  • Gdańsk, Poland
    • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
  • Katowice, Poland, 40-635
    • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  • Kraków, Poland
    • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
  • Kraków, Poland
    • Jacek Legutko
  • Lubin, Poland
    • Miedziowe Centrum Zdrowia s.a.
  • Poznań, Poland
    • Marek Grygier
  • Warszawa, Poland
    • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
  • Wrocław, Poland
    • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
  • Zabrze, Poland
    • Third Department of Cardiology, Medical University of Katowice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

A total of 305 unselected patients were included in the pooled analysis, of whom 203 (66.6%) patients were treated with a PCI and 102 (33.4%) with a CABG.

Description

Patients were divided into two separate cohorts for the analyses. The data included consecutive patients with ≥50% diameter UPLM-ISR, with or without multivessel coronary artery disease. Patients with an equivalent of UPLM-ISR: left main distal bifurcation disease, within the proximal 5 mm of the left anterior descending artery (LAD) or left circumflex artery (LCx) ostium (in the absence of significant angiographic stenosis in the left main coronary artery), were eligible. Patients who had protected LM-ISR, defined as the occurrence of at least one patent arterial or venous graft to the left coronary artery, other concomitant non-CABG procedure during surgery, were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UPLM-ISR	Procedure: PCI vs. CABG; PCI vs. CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MACCE	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
cardiac death	4 years
myocardial infarction	4 years
target vessel revascularization	4 years
stroke	4 years

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Publications and helpful links

General Publications

• Wanha W, Bil J, Kolodziejczak M, Kowalowka A, Kowalewski M, Hudziak D, Gocol R, Januszek R, Figatowski T, Milewski M, Tomasiewicz B, Kubler P, Hrymniak B, Desperak P, Kuzma L, Milewski K, Gora B, Los A, Kulczycki J, Wlodarczak A, Skorupski W, Grygier M, Lesiak M, D'Ascenzo F, Andres M, Kleczynski P, Litwinowicz R, Borin A, Smolka G, Reczuch K, Gruchala M, Gil RJ, Jaguszewski M, Bartus K, Suwalski P, Dobrzycki S, Dudek D, Bartus S, Ga Sior M, Ochala A, Lansky AJ, Deja M, Legutko J, Kedhi E, Wojakowski W. Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting for Treating In-Stent Restenosis in Unprotected-Left Main: LM-DRAGON-Registry. Front Cardiovasc Med. 2022 Apr 29;9:849971. doi: 10.3389/fcvm.2022.849971. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2001
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery bypass graft; in-stent restenosis; unprotected left main
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Stenosis; Coronary Artery Disease; Coronary Restenosis
• Other Study ID Numbers: 05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No